OCCLUSIVE IMPLANT AND DELIVERY SYSTEM
An occlusive implant can be delivered into a body vessel using a delivery assembly that can engage with at least a portion of the implant. The assembly can utilize an engagement member and an engagement socket or a catheter or sheath to removably couple the engagement member with the implant. When the implant is advanced to a target location in the body vessel, the implant can be released to restrict flow of a fluid through the vessel and/or promote occlusion of the vessel.
This application claims the priority benefit of U.S. Provisional Application No. 62/317,361, filed on Apr. 1, 2016, the entirety of which is incorporated herein by reference. The present application also incorporates by reference the disclosures of U.S. patent application Ser. No. 14/101,171, filed on Dec. 9, 2013 (086538-0046), U.S. Provisional Application No. 61/835,406, filed on Jun. 14, 2013 (086538-0032), U.S. Provisional Application No. 61/835,461, filed on Jun. 14, 2013 (086538-0034), U.S. Provisional Application No. 61/836,061, filed on Jun. 17, 2013 (086538-0038), U.S. Provisional Application No. 61/900,321, filed on Nov. 5, 2013 (086538-0040), U.S. Provisional Application No. 61/904,376, filed on Nov. 14, 2013 (086538-0041), U.S. Provisional Application No. 61/904,379, filed on Nov. 14, 2013 (086538-0043), and U.S. Provisional Application No. 61/939,659, filed on Feb. 13, 2014 (086538-0049), U.S. Patent App. No. 61/987,446, filed on May 1, 2014 (086538-0054), U.S. patent application Ser. No. 14/304,868, filed on Jun. 13, 2014 (086538-0057), and U.S. patent application Ser. No. 14/628,096, filed on Feb. 20, 2015 (086538-0063).
FIELDThe subject technology relates generally to apparatuses and methods for blood vessel occlusion using an occlusive implant that has a minimal delivery profile, thereby allowing the implant to be delivered to small-diameter body lumens.
BACKGROUNDRapid, well-controlled, and safe methods to limit bleeding in vessels have encouraged the development of endovascular devices and techniques, and their introduction into clinical practice. Early devices used balloons, either non-detachable or later detachable, in order to block vessels, for example, in the treatment of carotid-cavernous fistulas and saccular aneurysms.
Typically made from latex or silicone, balloons are delivered to a desired location in a vessel, then inflated in order to physically occlude the vessel. While other devices have since been developed, balloon occlusion remains in use, and is indicated for use in treating a variety of life-threatening conditions, including for example, giant cerebral and skull base aneurysms, traumatic and non-traumatic vessel injury or rupture, vertebro-vertebral arteriovenous fistulas, and pre-operative tumor resections.
Detachable balloons are also useful clinically in procedures outside of neurological intervention. For example, balloons can be useful in flow reduction procedures such as shunt occlusion in patients with transjugular intrahepatic portosystemic shunts and hepatic insufficiency, intrahepatic arterioportal fistulas, treatment of varicoceles, shunt occlusion in patients with a Blalock-Taussig shunt, obliteration of pulmonary arteriovenous fistulas, arteriovenous malformations or aortopulmonary anastomoses, coronary arteriovenous fistulas, or renal arteriovenous fistulas. Detachable balloons are also used in preoperative devascularization before surgical resection of organs such as the kidney.
Additionally, despite the increase in system and implant options for occluding a body lumen, traditional devices and technology have been limited in their ability to reach small body lumens. Accordingly, the present disclosure provides various delivery systems, engagement mechanisms, and implants that function to provide immediate occlusion of a blood vessel as well as reliable, precise placement and minimal or no migration when the implant is released into the blood vessel.
SUMMARYSome embodiments provided herein relate to vessel occlusion by delivery of radially expandable implants that can achieve immediate total occlusion of blood flow using one or more occlusive components that are coupled to a frame the implant. As noted above, the present disclosure provides delivery systems, engagement mechanisms, and implants that function to provide immediate occlusion of a blood vessel as well as reliable, precise placement and minimal or no migration when the implant is released into the blood vessel. Some embodiments of delivery systems, engagement mechanisms, implants, implant frames, and implant component configurations, expected delivered and expanded dimensions, and a description of target anatomy of some embodiments are provided herein.
The present disclosure provides various embodiments in which an implant can be delivered to a target area within a body lumen that has a very low diameter and therefore is difficult to reach using previous occlusion or delivery methods. Advantageously, some embodiments use a minimal number of components to effectuate occlusion of the body lumen, thus enabling the implant to be delivered using a low profile delivery catheter.
Accordingly, some embodiments provided herein relate to implantation in small blood vessels, such as from about 1 mm to about 20 mm, from about 2 mm to about 10 mm, or from about 3 mm to about 6 mm. The target delivery profile can be from about 1 Fr to about 20 Fr, and in some embodiments, from about 3 Fr to about 10 Fr. The target delivery profile can be about 8 Fr, about 7 Fr, about 6 Fr, about 5 Fr, about 4 Fr, about 3 Fr, or smaller.
Additionally, expansion of the implant can provide sufficient radial force against the inside wall of a vein. Some embodiments can comprise features or means configured to minimize backflow of blood or minimize venous insufficiency. For example, treatment applications for embodiments of the device can include ilio-femoral venous obstruction and chronic iliac venous outflow obstruction as a result of venous disease.
Some embodiments of the implants provided herein can be manufactured via several methods including shape-setting of drawn wire, chemical etching of a NiTi (nitinol) sheet of material, laser cutting of a tubular member, such as a material sheet or tubing, and/or electrical discharge machining (EDM) of a tubular member, such as a material sheet or tubing. Additionally, other alloys may also be employed in some circumstances, such as tantalum titanium and tantalum platinum titanium.
The implants disclosed herein can comprise flexible and/or shape memory materials such that they may be distorted from an expanded shape to a smaller diameter or straight shape to allow for delivery to a target location by way of a minimally invasive catheter-based approach.
In accordance with some embodiments, the implant can comprise a frame and an implant cover, cover component, or cover material. The frame can be covered with a non-permeable material, sealed at one or both ends to occlude blood flow. The cover component can comprise ePTFE tubing, film, and/or suture for attachment purposes. Additionally, the cover component may be fibrous, mesh-like, or impermeable in density.
The implant frame and/or cover component can comprise a collagen coating or collagen treatment to improve anchoring of the implant in the target vessel. The collagen can be configured to promote cell adhesion to implant materials, thereby facilitating improved support for the implant and vessel structure while acting as an anti-migration feature for the implant.
The implant frame can comprise a straight or constant diameter, a tapering diameter, or sections of variable diameter extending over its length, which can facilitate anchoring within a vessel and optimal deployment function.
Some embodiments of the systems and devices disclosed herein address the unmet need for a device that can provide a fast, precise and reliable way to close a bodily lumen. In some embodiments as used herein, occlusion may refer to partial or complete occlusion that can be temporary or permanent.
Frame configurations, expected delivered and expanded dimensions, and a description of target anatomy of some embodiments are provided. Some embodiments are provided by which the assembly, catheter, and/or implant can be advanced over a guidewire, thus allowing treatment of tortuous, distal, or smaller vessels in the vasculature. Aspects of implants, catheters, and delivery devices that can be utilized in combination with the implants, systems, methods, and features disclosed herein are disclosed in: U.S. patent application Ser. No. 12/826,593, filed on Jun. 29, 2010 (086538-0012); U.S. patent application Ser. No. 13/367,338, filed on Feb. 6, 2012 (086538-0018); U.S. patent application Ser. No. 12/906,993, filed on Oct. 18, 2010 (086538-0014); U.S. patent application Ser. No. 13/828,974, filed on Mar. 14, 2013 (086538-0030); U.S. Patent App. No. 61/835,406, filed on Jun. 14, 2013 (086538-0032); U.S. Patent Application No. 61/836,061, filed on Jun. 17, 2013 (086538-0038); U.S. patent application Ser. No. 14/044,794, filed on Oct. 2, 2013 (086538-0039); U.S. Patent App. No. 61/904,376, filed on Nov. 14, 2013 (086538-0041); U.S. patent application Ser. No. 14/101,171, filed on Dec. 9, 2013 (086538-0046); U.S. patent application Ser. No. 14/304,868, filed on Jun. 13, 2014 (086538-0057); U.S. patent application Ser. No. 14/622,729, filed on Feb. 13, 2015 (086538-0063); U.S. patent application Ser. No. 14/697,547, filed on Apr. 27, 2015 (086538-0067), and U.S. patent Ser. No. 14/973,414, filed Dec. 17, 2015 (086538-0074), the entirety of each of which is incorporated herein by reference.
Some embodiments of the implant can be used for purposes of tumor devascularization, calibrated flow and pressure reduction, reducing traumatic bleeding or hemorrhage, high-flow vascular malformations, vascular or airway volume reduction procedures, treatment of a target lesion, treatment and embolization of incompetent venous systems in low extremities (i.e., legs and lower abdominal area), treatment varicose veins in the leg (i.e., great saphenous vein and spider veins in deeper system), attending to other indications such as arterio-venous malformation (AVM), pelvic varices, and other such issues.
Additional features and advantages of the subject technology will be set forth in the description below, and in part will be apparent from the description, or may be learned by practice of the subject technology. The advantages of the subject technology will be realized and attained by the structure particularly pointed out in the written description and embodiments hereof as well as the appended drawings.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology.
The accompanying drawings, which are included to provide further understanding of the subject technology and are incorporated in and constitute a part of this specification, illustrate aspects of the subject technology and together with the description serve to explain the principles of the subject technology.
In the following detailed description, numerous specific details are set forth to provide a full understanding of the subject technology. It should be understood that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.
While the present description sets forth specific details of various embodiments, it will be appreciated that the description is illustrative only and should not be construed in any way as limiting. It is contemplated that although particular embodiments of the present inventions may be disclosed or shown in particular contexts, such embodiments can be used in a variety of endoluminal applications. Various applications of such embodiments and modifications thereto, which may occur to those who are skilled in the art, are also encompassed by the general concepts described herein.
The present disclosure provides various embodiments of implant delivery systems and expandable occlusive implants that have a low-profile delivery configuration through a catheter, as well as methods of using the systems and implants. The implant can at least partially occlude or block flow in a body lumen, such as a blood vessel. Some embodiments can be configured to provide complete and immediate occlusion of target lumen using a low-profile implant having a frame and an occlusive component coupled to the frame. The implant can comprise a frame and a nonstructural occlusive component coupled to the frame that can both be positioned in a substantially linear configuration to minimize the cross-sectional profile of the implant in the delivery configuration. Thus, the implant can provide rapid and/or complete occlusion while enabling the implant, catheter, or system to have a low delivery profile, allowing the implant to be implanted into body lumens having a diameter of between about 1 mm and about 10 mm or between about 1 mm and about 20 mm.
For example, the catheter can define an outer diameter of less than 2 Fr (less than 0.667 mm), about 2 Fr (about 0.667 mm), about 3 Fr (about 1 mm), about 4 Fr (about 1.333 mm), about 5 Fr (about 1.667 mm), about 6 Fr (about 2 mm), about 7 Fr (about 2.333 mm), about 8 Fr (about 2.667 mm), about 9 Fr (about 3 mm), about 10 Fr (about 3.333 mm), about 11 Fr (about 3.667 mm), or about 12 Fr (about 4 mm), about 13 Fr (about 4.333 mm), about 14 Fr (about 5.667 mm), about 15 Fr (about 6 mm), or any dimension therebetween. These dimensions are provided for illustrative purposes only, and the size of the catheter disclosed herein can vary from these sizes.
According to some embodiments, a reduced diameter or reduced cross-sectional profile of the occlusive implant can be achieved by using a frame structure that can be collapsed or elongated into a substantially linear configuration. Further, the frame structure can have a nominal profile that is less than about five or ten times the cross-sectional profile of the filament(s) or wire forming the frame structure. For example, in some embodiments, the frame structure can be formed using at least one elongate wire that is drawn into a substantially linear configuration and moved through a catheter lumen toward the target site. Some embodiments can comprise two or more elongate wires that can be drawn into substantially elongate linear configurations. Accordingly, various embodiments can be provided in which the elongate wires are drawn into a minimum profile configuration that allows the stent to assume a collapsed configuration having a cross-sectional profile that allows the stent to be loaded and delivered using a very small gauge catheter.
Some embodiments of the implant frame can be comprise one or more features, such a variable pitch, an alternating pitch, a consistent pitch, a dual wire loop configuration, a single occlusive member, multiple occlusive members, occlusive members having different structures or material types, occlusive member coatings, and/or other features disclosed herein. Further, some embodiments can be used with valves, covers, fibrous membranes, and the like, such as disclosed in Applicant's copending U.S. patent application Ser. No. 14/304,868, filed on Jun. 13, 2014 (086538-0057), the entirety of which is incorporated herein by reference. Further, in accordance with some embodiments, the implants and delivery systems can be used in combination with image-guided placement techniques, such as fluoroscopy and the like. Additional details regarding these and other features are provided further below.
Occlusive ImplantsReferring to the side section view of
In some embodiments, an angle between a pair of coupled hoop structures can be dependent upon the diameter of each coupled hoop structure. In an example, the diameter of hoop structure 100a can be greater than the diameter of hoop structure 100b, and the diameter of hoop structure 100b can be greater than the diameter of hoop structure 100c. Hoop structure 100a can be coupled to a circumference of hoop structure 100b, and hoop structure 100c can be coupled to a circumference of hoop structure 100b that can be opposite of hoop structure 100a. When positioned within a lumen 20 having a diameter that is less than the diameter of hoop structure 100c, an angle a-b between hoop structure 100a and hoop structure 100b can be greater than an angle b-c between hoop structure 100b and hoop structure 100c.
Referring now to
The first elongate wire 202 and the second elongate wire 204 are coupled together at a plurality of positions along the axis 2 to interconnect the first and second wires 202 and 204 and longitudinally secure the first and second wires 202 and 204 relative to each other. In some embodiments illustrated in
In an expanded configuration in which the first and second wires 202 and 204 are resiliently spaced apart from each other, the first and second wires 202 and 204 form a hoop structure between a pair of adjacent positions where first elongate wire 202 is coupled to the second elongate wire 204. The hoop structure can have a rounded shape in the expanded configuration. In some embodiments, the hoop structure can have a circular shape in the expanded configuration. In some embodiments, the first and second wires 202 and 204 can form at least four, five, six, seven, eight, nine, ten, or more hoop structures. In some embodiments, like the example embodiments illustrated in
In some embodiments, each of the first and second wires 202 and 204 has a diameter of 0.006 inch. The first elongate wire 202 and the second elongate wire 204 can be coupled together at a plurality of positions along a longitudinal length of the frame 200 to interconnect and secure the first and second wires 202 and 204 relative to each other.
For example, referring to the detail view of
Referring back to
Referring to
For example, the first and second loops 306, 308 can extend along a circumference of the frame while the helical section 302 extends at an angle or in a helical direction relative to the first and second loops 306, 308. The first and second loops 306, 308 and the helical section 302 can be interconnected at opposing ends of the helical section 302. In some embodiments, the interconnection can be formed using a longitudinally extending coupling member that extends substantially parallel relative to the longitudinal axis 3. However, in some embodiments, the longitudinal coupling member can extend obliquely or at an angle relative to the longitudinal axis of the frame. The coupling member can have a length about equal to a length of the helical section 302 in its fully expanded state, as shown in
Optionally, the frame 300 can comprise a first elongate wire 302 and a second elongate wire 304 coupled together along the longitudinal length of the frame 300 to form the one or more loops and/or helical sections, as shown in
When the frame 300 includes first and second elongate wires 302 and 304, as shown in
Referring still to the frame 300,
Optionally, the frame forms a third loop at the first end of the frame. The third closed loop can be positioned such that the first closed loop can be interposed between the third closed loop and the helical section. The third closed loop can be formed by the first and second wires coupled to each other at a fifth location and diverging from the fifth location and converging towards the first location to form the third closed loop.
Optionally, the frame forms a fourth closed loop at the second end of the frame. The fourth closed loop can be positioned such that the second closed loop can be interposed between the fourth closed loop and the helical section. The fourth closed loop can be formed by the first and second wires diverging from the third location and converging toward each other at a sixth location to form the fourth closed loop.
It should be understood that the present disclosure is not limited to the embodiment of the frame 300 illustrated in
In some embodiments, the frame 400 can comprise a first elongate wire 402 and a second elongate wire 404 coupled together along the longitudinal length of the frame 400 to form the closed loop(s). In some embodiments of the present disclosure, the first and second elongate wires 402 and 404 can be coupled together by bonding or welding the wires. In some embodiments, the first and second elongate wires 402 and 404 can be twisted about each other to interconnect the wires.
The frame 400 may be formed as a first closed loop 406 at the first end of and a second closed loop 408 at the second end. Between the first and second closed loops, the frame can comprise one or more additional closed loops. For example, the frame 400 can comprise a third closed loop 410 and/or a fourth closed loop 412. In accordance with some embodiments, the first and second closed loops 106 and 408 can have the same or different diameter, and the third and fourth closed loops 410 and 412 have the same or different diameter. In some embodiments, all of the closed loops can have the same or different diameters.
Where the frame 400 can comprise first and second elongate wires 402 and 404, the first closed loop 406 can be formed by the first and second wires coupled to each other at a first location, then diverging from the first location, and converging toward each other at a second location to form the first closed loop. Each closed loop thereafter can be formed by the first and second elongate wires 402 and 404 diverging from each other at the location where the wires are coupled, and converging toward each other at the next location to form the next closed loop. In some embodiments, the portions of the frame 400, where the first and second elongate wires 402 and 404 are coupled, extends parallel to the axis 4.
In forming the frame 200, 300, 400 or others disclosed herein, the individual wires can be shaped or heat set into a curvilinear configuration before and/or after being joined with a corresponding wire to create the respective frame configuration. The wires (whether coupled together to form the frame or individually) can comprise a metal or polymer material, and can be heat set, molded, or otherwise shaped to have a resilient, self-expanding, bistable, and/or expandable shape. The frames can be self-expandable or balloon expandable.
Although embodiments of the present disclosure include a frame having a cylindrical profile in an expanded configuration, some embodiments include a frame having other shape profiles. For example, referring to
In accordance with some embodiments, a delivery system is provided that can control release and expansion of the implant at a target site within a lumen of a vasculature. The delivery system may comprise an implant carrier assembly with an occlusive implant retained therein. The implant carrier assembly can be inserted into a lumen where the occlusive implant can be positioned. The occlusive implant can then be deployed and released from the implant carrier assembly and permitted to expand within the lumen.
For example,
In some embodiments, the implant carrier assembly 500 can comprise a catheter 512 having a lumen that extends between a proximal portion and a distal portion thereof, and the engagement member 504 and sheath 508 can be retained within the lumen of the catheter 512. The lumen of the catheter 512 can be configured to permit the distal end portion of the sheath 508 to be movable within the lumen proximal to or distal to the distal portion of the catheter 512.
Referring to
In some embodiments, the socket 506 can be formed separately from the engagement member 504 and coupled to the engagement member 504. Such an embodiment as illustrated in
The distal end portion of the socket 506 can include a first void extending proximally toward the engagement member 504. In some embodiments, the first void extends a first depth into the socket 506. A second void extends into a proximal end of the socket 506 towards the distal end. In some embodiments, the second void extends a second depth into the socket proximally towards the first void. In some embodiments, the second depth can be less than the first depth.
In some embodiments, the first void has a first cross-sectional width along a first portion proximal to the distal end of the socket 506, and a second cross-sectional width along a second portion that is proximal to the first portion, wherein the second cross-sectional width is greater than the first cross-sectional width.
The first void is configured to receive, engage, and/or restrain a proximal portion of the occlusive implant 502 within the implant carrier assembly 500. In a restricted position, the proximal portion of the occlusive implant 502 is positioned in the first void between the socket 506 at and an inner surface of the sheath 508.
In some embodiments, the proximal portion of the occlusive implant 502 can comprise a proximal coupling member 510. The proximal coupling member 510 can comprise an outer profile having a cross-sectional width or profile that can be greater than a cross-sectional sectional profile of the wire(s) or connecting portion of the frame width at the proximal portion of the occlusive implant 502. In some embodiments, the proximal coupling member 510 can comprise a sphere extending from an outer surface of the frame. The first void can comprise an inner profile that generally mates with, couples to, matches approximates, or is equal to or larger than an outer profile of the proximal coupling member 510 to permit the proximal coupling member 510 to be positioned within the socket. However, as illustrated, the outer profile of the proximal coupling member 510 can also be greater than the cross-sectional space created between the width, depth, or profile of the second void of the socket 506 and an inner surface of the sheath 508. Thus, the proximal coupling member 510 can be seated into the socket 506; however, because the proximal coupling member 510 cannot be passed distally beyond the second void of the socket 506, the proximal coupling member 510 can be retained or captured between the second portion of the socket 506 and the sheath 508 to collectively restrict longitudinal movement of the occlusive implant 502 out of the socket 506. This capturing or restrained will be maintained until the sheath 508 (or other sleeve used in addition to or in place of the sheath 508, such as the catheter 512, in some embodiments) is proximally retracted relative to the socket 506, thus exposing the proximal coupling member 510 and permitting the proximal coupling member 510 to separate from the first void of the socket 506.
Referring now to
Referring to
The implant carrier assembly 500, in some embodiments, can comprise a handle assembly. The handle assembly can include a first slidable member and a second slidable member. The first slidable member can be coupled to a proximal end of the engagement member 504, and the second slidable member can be coupled to a proximal end of the sheath 508. The first and second slidable members can have a first configuration in which the first and second slidable members are coupled together. In the first configuration, the first and second slidable members can move in unison together as a single unit. For example, the first and second slidable members may be advanced through the catheter 512 such that a portion of the engagement member 504 and sheath 508 extend distal to the distal end of the catheter 512, as illustrated in
As discussed with respect to
The carrier assembly can comprise an ejection component that extends within or along the socket and can be used to facilitate disengagement between the implant and the socket. An ejection component can be beneficial to ensure that the implant is fully disengaged from the carrier assembly. The ejection component can comprise a flexible, elastic, or resilient material that can be manually or self-actuated in order to create separation between the carrier assembly and the coupling of the implant, in order to separate the implant from the carrier assembly. In some embodiments, the ejection component can comprise a wire or a resilient compressible pad that can be coupled to or extend across at least a portion of the socket, and in some embodiments, be coupled to or extend across at least a portion of the void of the socket. Further, the ejection component can be manually actuated by pushing or pulling the ejection component relative to the socket.
For example, as illustrated in
In the recessed configuration, the ejection wire 608 can be slack and extend along a bottom surface of the socket 612. In the recessed configuration, the ejection wire 608 permits the proximal portion of the occlusive implant 602 to be positioned in the socket 612. For example, referring to
After the implant 602 has been positioned within a body lumen and expanded as discussed above with regard to
As noted above, in some embodiments, the ejection wire 608 can be a flexible line that can be coupled to the distal end of the engagement member 604 and extends from the socket 612 toward a proximal end of the implant carrier assembly 600. A proximal portion of the ejection wire 608 may extend through a passage in the engagement member 604 or catheter. For example, in some embodiments, the ejection wire 608 can extend from the socket 612 between an outer surface of the engagement member 604 and an inner surface of the lumen of the catheter 606 or within a separate lumen of the catheter 606. In some embodiments, the ejection wire 608 can extend proximally to and be coupled to an ejection actuator of a handle assembly. The ejection actuator can enable a clinician to manually actuate the ejection wire 608, thereby causing the ejection wire to move to the ejection configuration, e.g., from slack to taut.
In some embodiments in which the ejection component comprises a self-actuating member, the occlusive implant 602 can be automatically released from the implant carrier device 600 when the socket 612 is positioned distal to the distal end of the catheter 606. For example, the ejection wire 608 may comprise a resilient resiliently flexible material that extends transversely across a portion of the socket 612 in a recessed configuration. When the occlusive implant 602 is positioned between the socket 612 an inner surface of the catheter 606 (e.g.,
Accordingly, in some embodiments, the ejection wire can comprise a shape memory material. For example, the shape memory material permits the occlusive implant 602 to displace the ejection wire 608 in an ejection or deactivated configuration. However, when the shape memory material is activated (e.g., when compressive forces from the catheter or sheath are removed) or self-actuated, the ejection wire can expand or move away from an inner surface of the socket and urge the occlusive implant 602 out of the socket 612.
Further, although the ejection component is discussed as being an elongate wire in the illustrated embodiments, the ejection component can comprise a short wire or band coupled to the proximal and distal ends of the socket itself, one or more cantilevered tabs or flaps that are coupled to a perimeter of the void of the socket and have free, resilient ends extending into the void that are biased toward an ejection configuration, and/or other self-expanding, resilient, or elastic components.
In accordance with some embodiments, the core member 702 may include a lumen 704 extending between the proximal and distal ends. The lumen 704 can be configured to receive the release component there within, which in some embodiments can comprise an elongate wire.
Optionally, the core member 702 can comprise a slot for engaging a free end of the release component to facilitate or retain the release component in the engaged position. For example, as illustrated in
At the distal end portion of the core member 702, a release wire 712 can be configured to engage the occlusive implant 708. The release wire 712 can be operably coupled to or positioned at the distal end portion of the core member 702. For example, the release wire 712 can comprise an elongate wire that can extend within a lumen 704 of the core member 702. The release wire 712 can comprise a distal portion extending out of the core member lumen 704 beyond the core member distal end. In some embodiments, the distal portion of the release wire 702 can comprise a hook or deflectable segment that can move between engaged and disengaged positions. The release wire 702 can comprise a deflectable, resilient, elastic, shape memory, and/or biased component or material. Further, in some embodiments, the release wire 702 can maintain a generally hook-shaped, looped, or bent configuration in engaged and disengaged positions. Alternatively, the release wire 702 can move from a hook-shaped, looped, or bent configuration to a substantially straight or less-bent configuration when moving from the engaged position to the disengaged position.
In accordance with some embodiments, in the engaged position, as illustrated in
In the engaged position, the occlusive implant 708 can be retained by the implant carrier assembly 700. For example, a proximal portion of the occlusive implant frame 714 may include an implant proximal coupling member 716 or otherwise be joined or welded in a proximal segment thereof. In any of such embodiments, first and second wires of the occlusive implant 708 can thereby converge and be joined, for example, by welding or otherwise extending through the implant proximal coupling member 716, if used. To retain the occlusive implant 708, the distal portion of the release wire 712 can extend through the lumen 704, loop around the implant (e.g., through the proximal ring or hoop of the implant, around proximal coupling member 716, or around/into a slot or hook on the proximal coupling member 716), and terminates in the slot 706. The loop of the release wire 712 can constrain longitudinal movement of the implant 708 relative to the core member 702. In some embodiments, the release wire 712 can extend through a first lumen of the core member 702, loop around the implant proximal coupling member 716, and extend through a second lumen of the core member 702.
In some embodiments, the distal portion of the release wire 712 comprises a length of at least about twice as long as a longitudinal length of the implant proximal coupling member 716. The distal portion of the release wire 712 may comprise a length of at least about 2.5 times as long as a length of the implant proximal coupling member 716.
Once in the engaged position, the assembly 700 can be advanced through an introducer catheter toward the target site within the body lumen. Thereafter, referring to
Accordingly, the implant carrier assembly 700 may be actuated or moved to the released position when the core member distal end is positioned distally beyond the sheath distal end. In the released position, illustrated in
However, in some embodiments, the release wire can also or instead be configured to be actuated or moved into the released position while the distal end of the core member 702 is positioned within the lumen of the sheath 710. For example, the core member 702 may include a release mechanism associated with the distal end of the release wire 712, such as an electrolytic detachment or dissolvable bond that can be actuated by the clinician or actuated after a certain period of time in the presence of body fluid, thereby permitting the wire to be released and the core member 702 directed away from the occlusive implant 708. In another example, a release wire 712 can comprise a shape memory material that may be actuated by the clinician to engage or release the occlusive implant 708 by proximally retracting the wire within the lumen. Further, some embodiments can optionally omit the use of the sheath 710 and rely solely on manual actuation and disengagement of the wire 712 by the clinician.
For example, in some embodiments, referring to
Referring to
Referring to
Each of the arms 810 can comprise a protrusion 812 extending radially inwardly. Referring to
Referring to
In some embodiments, the outer surface of the pusher 814 can be configured to engage an inner surface of the passage through the base 808 of the engagement arms 810 and between the arms 810. The pusher 814 can be configured to extend through the passage of the engagement arms 810. In some embodiments, a length of the pusher 814 between the proximal and distal ends is less than a length between the proximal end and the protrusion 812 of each arm 810. Further, the pusher 814 can be longitudinally movable relative to the arms 810 in order to be advanced distally relative to the arms 810 to push an implant coupling member 816 distally beyond the arms 810. For example, in embodiments in which the arms 810 are not resiliently biased to an open or expanded state after being pushed distally beyond the distal end of the sheath 804, the pusher 814 can be actuated by the clinician to distally advance the implant coupling member 816 distally beyond the arms and protrusions thereof in order to disengage the implant coupling member 816 therefrom.
In an engaged position, illustrated in
Referring to
Alternatively, or in addition to some embodiments comprising a pusher that is distally movable relative to one or more arms, the engagement mechanism 806 can comprise one or more arms 810 that can be biased to radially separate from the longitudinal axis of the sheath or separate from each other when the arm(s) is positioned distal to the distal end of the sheath 804. For example, some embodiments can be configured such that the arm(s) and the pusher are formed as a unitary component or from a single, continuous piece of material, and the arm(s) can be biased or spring away from the longitudinal axis of the sheath. Thus, when the engagement mechanism 806 moves beyond a distal end of the sheath 804, the engagement mechanism 806 can automatically release the implant therefrom.
For example, the arm(s) 810 can comprise a shape memory material that can be activated to cause the arm(s) to move from one position to another (e.g., an alloy or polymer that can be activated by temperature, electricity, light, chemical, or otherwise). When the shape memory material is activated, the arms 810 bias radially outward, away from each other, thereby permitting the occlusive implant 802 to be released. In some embodiments, the shape memory material can maintain the arm(s) 810 in a radially collapsed configuration, wherein the implant proximal coupling number 816 is engaged by the engagement arms 810 until the shape memory is activated and causes the arm(s) 810 to separate from the longitudinal axis or other arms, thus opening the engagement region and allowing the proximal coupling member 816 to be separated therefrom.
Optionally, in some embodiments, the pusher 814 can be distally advanceable within the sheath 804 lumen to move the engagement arm(s) 810 from the engaged position to the disengaged position, as illustrated in
The implant carrier assembly, in some embodiments, can comprise a handle assembly. The handle assembly can comprise at least one slidable member to actuate the engagement mechanism of the assembly. For example, the slidable member can be coupled to the pusher/engagement arm(s) to controlled distal advancement of the pusher/engagement arm(s) relative to the sheath. The assembly can also be configured to comprise two slidable members, one being operably connected to the pusher/engagement arm(s) and the other being operably connected to the sheath. The assembly can also be configured to comprise two slidable members, one being operably connected to the pusher and the other being operably connected to the engagement arm(s). Moreover, the assembly can also be configured to comprise three slidable members, one being operably connected to the pusher, one being operably connected to the engagement arm(s), and the other being operably connected to the sheath. Other variations and configurations can be performed within the scope of the disclosure presented herein. These slidable members can be coupled to each other and/or to the guide catheter or sheath in order to maintain a fixed relative positioning thereof, as discussed with respect to some embodiments herein.
In accordance with some embodiments,
Referring to
Referring to
Referring to
In some embodiments, the first slidable member 902 can be coupled to a proximal end of an engagement member, a core member, or a pusher member as described herein, and the second slidable member 904 can be coupled to a proximal end of the sheath or one or more engagement arms, as described herein.
The first and second slidable members can have a first configuration, illustrated in
For example, to insert and deploy and occlusion implant, the catheter can be advanced through a lumen, e.g., an artery, with the first and second slidable members in the locked position with the catheter. The catheter can be advanced through the lumen until the distal end of the catheter is positioned where the occlusion implant is to be placed. Next, the locking pin can be removed and the first and second slidable members can be directed together through the catheter in the first configuration such that the distal ends of the first and second slidable members approach the distal end of the catheter. The first and second slidable members can therefore advance the occlusion implant to a location at which the implant can be released from the catheter distal end into the lumen. To release the proximal portion of the occlusion implant from the implant carrier assembly, the spacer pin can be removed, and the first slidable member can be further advanced through an relative to the second slidable member, thereby directing a proximal portion of the occlusion implant through the distal portion of the second slidable member. Next, implant carrier assembly, including, for example, the first and second slidable members and the catheter, can be retracted from the lumen.
In some configurations, when the distal end of the occlusion implant begins to deploy to the expanded configuration, the first and second slidable members and the catheter can be retracted from the lumen such that the remaining portion of the occlusion implant can be deployed from the implant carrier assembly. Because the occlusion implant expands as it is release from the implant carrier assembly, the first and second slidable members and the catheter may be retracted at different rates.
Cover Component FeaturesAs disclosed above, in some embodiments, the implant can comprise at least one cover component, membrane, mesh, or patch to assist in occluding, partially or completely, a luminal structure in which a respective implant is deployed. A cover component may be attached to one or both ends or support elements of an implant and/or to a middle region of an implant. The cover component can be configured as those disclosed in copending U.S. patent application Ser. No. 14/628,096, filed on Feb. 20, 2015 (086538-0063), the entirety of which is incorporated herein by reference.
Referring to
In accordance with some embodiments, including any of the implant structures disclosed herein, an implant can be provided in which one or more of the hoop members comprises a cover component, such as that discussed with respect to the ePTFE. For example, hoop members at the proximal and distal ends of the implant can comprise ePTFE membranes that can facilitate blockage of flow immediately upon release of the implant.
In some embodiments, a cover component can comprise at least one of a polyurethane, a polyanhidrate, PTFE, ePTFE, silicone, and other suitable materials known to those of ordinary skill in the art. In some embodiments, cover components may be elastic. In some embodiments, cover components may be permeable or non-permeable.
Some embodiments can be configured such that the cover component can carry biocompatible medications or materials, such as hydrogels, collagens, or embolic materials. Further, the implant can comprise a cover component that extends around and/or within the support frames in a variety of ways.
The cover component can comprise a mesh material that is attached to support elements of the frame of an implant. The cover component can be formed from a tubular material that extends around and encloses the support elements, and in some embodiments, the entire frame of an implant. However, the cover component can also be adhered or coupled to the support elements by themselves. In some embodiments, the cover component can comprise a single layer of material.
Additionally, some embodiments can be configured such that when released into a body lumen, the cover component can facilitate occlusion of the lumen through the use of hydrogels, collagens, adhesives, or other coatings that disrupt or reduce flow through the lumen of the implant.
In some embodiments, an average thickness of a cover component can be between about 0.0005 inches and about 0.006 inches. In some embodiments, the average thickness of a cover component may be less than about 0.0005 inches or greater than about 0.006 inches. In certain embodiments, an average thickness of a distal portion of a cover component is greater than an average thickness of a proximal portion of a cover component. Such a configuration may ensure that more flow may be reduced at the distal portion of a cover component.
In some embodiments, the average thickness of the distal portion of a cover component is between about 0.002 inches and about 0.012 inches. In some embodiments, the average thickness of the distal portion of a cover component may be less than about 0.002 inches or greater than about 0.012 inches. In some embodiments, the average thickness of the proximal portion of a cover component is between about 0.0005 inches and about 0.006 inches. In some embodiments, the average thickness of the proximal portion of a cover component may be less than about 0.0005 inches or greater than about 0.006 inches.
Valve MechanismsSome embodiments of the implant frame can comprise a valve mechanism that allows a portion of the implant frame to collapse, thus restricting flow through the implant, as disclosed in copending U.S. patent application Ser. No. 14/304,868, filed on Jun. 13, 2014, the entirety of which is incorporated herein by reference. Further, in accordance with some embodiments, the valve mechanisms disclosed herein can be used in a manner suitable for deploying an embolic material to a target region, such as for cancer therapy, as disclosed in copending U.S. patent application Ser. No. 14/101,171, filed Dec. 9, 2013, the entirety of which is incorporated herein by reference.
Implant Materials and CoatingsAccording to some embodiments of the subject technology, the support frame of the implant may comprise at least one of stainless steel, nickel titanium (NiTi), cobalt chromium (CoCr), titanium, a polymer, a polyester based material, a tyrosine based polycarbonate, a polyethylene based material, Teflon (e.g., including expanded Teflon), and other suitable materials known to those of ordinary skill in the art. In some embodiments, support frame may comprise at least one of polyethylene, polyglicolide, polylactide, c-caprolactone, polycarbonate, hydroxyalkanote, para dioxinine, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), PLA, PGA, PLLA, PDLLA, PDO, PCL, and other suitable materials known to those of ordinary skill in the art.
In some embodiments, support frame and/or occlusion membrane, may comprise a bioabsorbable material, beneficially allowing for their controlled degradation. In some embodiments, support frame and/or occlusion membrane may be formed of bioabsorbable material to have a controlled degradation anywhere between about 3 months to about 3 years depending on the desired application of support frame. In some embodiments, the controlled degradation may be less than about 3 months or greater than about 3 years. For example, hydrolysis of ester linkages or effects of enzymatic degradation may be utilized for the controlled degradation.
In some embodiments, components of the implants disclosed herein, including the frame, cover component, and/or occlusive components and/or materials, may be surface finished and/or coated with various suitable agents, such as hydrogels, collagens, drugs, adhesives, and the like, to facilitate expansion of the implant, facilitate engagement of the implant within the body lumen, and/or promote occlusion by the implant of the body lumen. For example, the support frame can be coated with a material to facilitate expansion within and engagement between the implant and the inner surface of the vessel or lumen. Further, the frame, cover component, and/or occlusive components and/or materials may be coated with biological glue, hydrogels, collagens, drugs, and/or adhesive materials. In some embodiments, support frame may be coated with a friction-resistant coating (e.g., a friction-resistant polymer coating). In some embodiments, radio-opaque markers may be located on support frame or occlusion membrane for endovascular or other image-guided procedures. In some embodiments, the radio-opaque marker may be a platinum iridium alloy or other suitable markers known to those of ordinary skill in the art.
Medical Applications and Procedures for Some EmbodimentsThe occlusive implants, catheters, systems, and methods can be used in a variety of clinical applications, such as rapid, well-controlled, and reliable temporary or permanent vessel occlusion, stenting, or other functions in luminal structures of a patient. According to some embodiments, the implants, catheters, systems, and methods disclosed herein can be used for percutaneous, peripheral occlusion of the arterial and venous vasculature. However, the luminal structure may comprise at least one of a blood vessel, a body organ, a lung, an airway, a Fallopian tube, a cervical canal, a vagina, a cervix, a vas deferens, a bronchus, a ureter, a colon, a rectum, an anus, a bio duct, a pancreatic duct, or other suitable tubular structures known to those of ordinary skill in the art. In some embodiments, the implants, catheters, systems, and methods disclosed herein may be used for temporary occlusion in cases of lung disease, or for temporary occlusion of female reproductive organs for contraceptive purposes. In some embodiments, the implant(s) may be removed, or flow may be restored through the luminal structure to restore original organ functions.
Some embodiments of the occlusive implants, catheters, systems, and methods can be used to treat pelvic venous incompetence, varicocele, gonadal vein for pelvic varices in females with chronic pelvic pain, stop blood loss from a damaged blood vessel due to a traumatic arterial injury, stop hemorrhage caused by a neoplasia, or close an abnormal blood vessel or blood vessels supplying a vascular anomaly such as arteriovenous malformations or arteriovenous fistulas, and other conditions.
Further, some embodiments may be used for various endoluminal occlusion procedures, including procedures for the lungs (e.g., selective endobronchial occlusion for lung reduction, occlusion of bronchopleural or bronchocutaneous fistulas, endovascular occlusion of pulmonary AVMs and fistulas or aortopulmonary anastomoses) and procedures for reproductive organs (e.g., endoluminal occlusion of vas deferens or Fallopian tubes for minimally-invasive contraceptive intervention, endovascular occlusion of varicocele in males and low abdominal gonadal veins for reducing or completely eliminating chronic pelvic pain syndrome in females). Some embodiments may be used for stopping blood loss from a damaged blood vessel, closing an abnormal blood vessel or a blood vessel supplying a vascular anomaly, or interrupting blood supply to an organ or part of an organ for permanent devascularization (e.g., closure of splenic artery in spleen laceration, devascularization of tissues involved by neoplastic process, either pre-operatively or as a palliative measure). Some embodiments may be used for various endovascular (e.g., neural and peripheral) procedures including procedures for giant cerebral and skull base aneurysms (ruptured and non-ruptured), head and neck arteriovenous fistulas, dissecting intracranial and extracranial vessels, traumatic and non-traumatic vessel injury or rupture (e.g., pelvic hemorrhages in trauma patients, carotid blow-out in patients with head and neck cancers, hemorrhage induced by a neoplasia, and other such issues), and devascularization prior to (or as an alternative to) surgical resection of various organs or tumors.
Furthermore, some embodiments may be used for various organs, including for example, the spleen (e.g., endovascular occlusion as a preoperative intervention or as an alternative to surgical resection with indications including traumatic hemorrhage, hypersplenism, bleeding secondary to portal hypertension or splenic vein thrombosis, and various disorders such as thalassemia major, thrombocytopenia, idiopathic thrombocytopenic purpura, Gaucher disease, and Hodgkin disease), the liver (e.g., occlusion of portal veins collaterals as adjunct to a transjugular intrahepatic portosystemic shunt (TIPS), occlusion of the TIPS itself in cases of encephalopathy, occlusion of intrahepatic arterioportal fistulas), the kidney (e.g., endoluminal ureteral occlusion for intractable lower urinary tract fistula with urine leakage, or for the treatment of uretero-arterial fistulae, endovascular occlusion as an alternative to surgical resection for end-stage renal disease or renovascular hypertension requiring unilateral or bilateral nephrectomy and renal transplant with native kidneys in situ), and the heart (e.g., occlusion of coronary arteriovenous fistulas, transarterial embolization of Blalock-Taussig shunts). The application of the implants, catheters, systems, and methods disclosed herein is not limited to applications for human patients, but may also include veterinary applications.
Illustration of Subject Technology as ClausesThe subject technology is illustrated, for example, according to various aspects described below. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology. It is noted that any of the dependent clauses may be combined in any combination, and placed into a respective independent clause, e.g., clause 1 or clause 55. The other clauses can be presented in a similar manner.
Clause 1. An expandable device for delivery to a target location in a body lumen, the device comprising: first and second elongate wires extending along a longitudinal axis and being twisted helically about each other at a plurality of positions along the axis to interconnect the first and second wires and longitudinally secure the first and second wires relative to each other, wherein the first and second wires form a hoop structure between each pair of adjacent positions, each hoop structure having an expanded configuration in which the first and second wires are resiliently spaced apart from each other and a collapsed configuration in which the first and second wires extend adjacent to or abut each other.
Clause 2. The device of Clause 1, wherein the first and second wires form at least four hoop structures.
Clause 3. The device of Clause 2, wherein the first and second wires form six hoop structures.
Clause 4. The device of any of the preceding Clauses, wherein each hoop structure has a rounded shape in the expanded configuration.
Clause 5. The device of any of the preceding Clauses, wherein each hoop structure has a circular shape in the expanded configuration.
Clause 6. The device of any of the preceding Clauses, wherein in the collapsed configuration, adjacent hoop structures extend in a substantially linear configuration along the longitudinal axis, and wherein in the expanded configuration, the adjacent hoop structures extend transverse relative to the longitudinal axis.
Clause 7. The device of any of the preceding Clauses, further comprising a cover member coupled to the device.
Clause 8. An expandable device for occluding a body vessel, the device comprising: a first closed loop, the first closed loop comprising first and second wires coupled to each other at a first location, the first and second wires diverging from the first location and converging toward each other at a second location to form the first closed loop; a helical section adjacent to the first closed loop, the first wire extending helically from the closed loop in a first direction and the second wire extending helically from the closed loop in a second direction, opposite the first direction, thereby forming the helical section; and a second closed loop, opposite the first closed loop. with the helical section disposed therebetween, the second closed loop comprising the first and second wires coupled to each other at a third location adjacent to the helical section, the first and second wires diverging from the third location and converging toward each other at a fourth location to form the second closed loop.
Clause 9. The expandable device of Clause 8, wherein the first and second wires each complete two helical revolutions in the helical section.
Clause 10. The expandable device of any of Clauses 8 or 9, further comprising a third closed loop, the first closed loop being interposed between the third closed loop and the helical section, the first and second wires coupled to each other at a fifth location and diverging from the fifth location and converging towards the first location to form the third closed loop.
Clause 11. The expandable device of any of Clauses 8-10, further comprising a fourth closed loop, the second closed loop being interposed between the fourth closed loop and the helical section, the first and second wires diverging from the third location and converging toward each other at a sixth location to form the fourth closed loop.
Clause 12. The expandable device of any of Clauses 8-11, wherein the expandable device comprises a substantially cylindrical expanded profile.
Clause 13. The expandable device of any of Clauses 8-12, further comprising a cover member coupled to the device.
Clause 14. An assembly for delivering an implant into a body vessel, the implant having a proximal coupling member, the assembly comprising: a sheath comprising a lumen, an inner surface, and a distal end; and an engagement member extending within the sheath lumen, the engagement member comprising a distal end portion having a socket extending from an outer surface of the distal end portion into the engagement member, the socket having an inner profile greater than an outer profile of the implant proximal coupling member to permit the implant proximal coupling member to be removably positionable within the socket, wherein in an engaged position, the socket is positioned proximal to the sheath distal end to permit the sheath inner surface and the socket to collectively restrict longitudinal movement of the implant proximal coupling member out of the socket, and wherein in a released position, the socket is positioned distal to the sheath distal end to permit the implant proximal coupling member to exit the socket.
Clause 15. The assembly of Clause 14, wherein the engagement member comprises a slotted hypotube and a distal band, the hypotube having inner and outer diameters, the band having an inner diameter equal to or greater than the hypotube outer diameter and an outer profile of the engagement member distal end portion to permit the engagement member distal end portion to be slidably receivable within the band.
Clause 16. The assembly of any of Clauses 14 or 15, wherein the hypotube outer diameter is less than 0.025″.
Clause 17. The assembly of Clause 16, wherein the hypotube outer diameter is about 0.018″.
Clause 18. The assembly of any of Clauses 14-17, wherein the socket of the engagement member distal end portion comprises a first void extending into the distal end portion at a first depth and a second void extending into the distal end portion at a second depth, less than the first depth, the second void extending from a distal end of the distal end portion proximally toward the first void.
Clause 19. The assembly of any of Clauses 14-18, wherein the engagement member comprises a core member coupled to the distal end portion, the core member having an outer diameter less than an outer diameter of the distal end portion.
Clause 20. The assembly of Clause 19, wherein the core member outer diameter is less than 0.020″.
Clause 21. The assembly of any of Clauses 19-20, wherein the core member outer diameter is about 0.014″.
Clause 22. The assembly of any of Clauses 14-21, further comprising a catheter having a lumen, the sheath extending within the catheter lumen.
Clause 23. The assembly of Clause 22, wherein the catheter has an outer diameter of about 0.036″.
Clause 24. The assembly of any of Clauses 22 or 23, wherein the catheter comprises a marker band at a distal end thereof.
Clause 25. The assembly of Clause 24, wherein the marker band has an outer diameter of about 0.040″.
Clause 26. The assembly of any of Clauses 14-25, further comprising a handle assembly, the handle assembly comprising (i) a first slidable member coupled to a proximal end of the engagement member and (ii) a second slidable member coupled to a proximal end of the sheath, the first and second slidable members having a first configuration in which the first and second slidable members are coupled together to move as a unit and a second configuration in which the first and second slidable members are movable relative to each other to cause the engagement member to move relative to the sheath.
Clause 27. The assembly of Clause 26, wherein the handle assembly comprises a spacer pin, the space or pin being removably engageable with the proximal end of the engagement member to secure a longitudinal position of the engagement member relative to the sheath.
Clause 28. The assembly of Clause 27, wherein the first slidable member comprises a first knob and the second slidable member comprises a second knob, the spacer pin being positionable between and in contact with the first and second knobs in the first configuration.
Clause 29. The assembly of any of Clauses 14-29, further comprising an ejection wire coupled to the engagement member distal end portion and extending proximally across the socket, the ejection wire having (i) a recessed configuration in which the ejection wire is slack and extends along a bottom surface of the socket and (ii) an ejection configuration in which the ejection wire is taut and extends transversely across the socket, wherein the ejection wire permits positioning of the implant proximal coupling member within the socket in the recessed configuration and movement of the ejection wire to the ejection configuration urges the implant proximal coupling member out of the socket.
Clause 30. The assembly of Clause 29, wherein the ejection wire extends proximally to a handle assembly, the handle assembly comprising an ejection actuator to permit proximal withdrawal of the ejection wire to cause the ejection wire to move to the ejection configuration.
Clause 31. An assembly for delivering an implant into a body vessel, the implant having a proximal coupling member, the assembly comprising: a sheath comprising a lumen, an inner surface, and a distal end; a core member extending within the sheath lumen, the core member comprising a lumen extending therethrough and a slot extending proximally from a distal end of the core member along an outer surface thereof; and a release wire extending within the core member lumen, the release wire having a distal portion extending out of the core member lumen beyond the core member distal end, wherein (i) in an engaged position, the core member distal end is positioned within the sheath lumen and the release wire distal portion reverses to loop into the core member slot to be interposed between the core member and the sheath inner surface and (ii) in a released position, the core member distal end is positioned distally beyond the sheath distal end and the release wire distal portion is positioned outside of the core member slot, wherein in the engaged position, the release wire distal portion loops around the implant proximal coupling member to constrain longitudinal movement of the implant proximal coupling member relative to the core member.
Clause 32. The assembly of Clause 31, wherein the release wire distal portion contacts the slot and the sheath inner surface in the engaged position.
Clause 33. The assembly of any of Clauses 31 or 32, wherein the release wire distal portion is resiliently biased away from the core member slot.
Clause 34. The assembly of any of Clauses 31-33, wherein the release wire distal portion is resiliently biased to a substantially straight configuration.
Clause 35. The assembly of any of Clauses 31-34, wherein the release wire distal portion comprises a length of at least about twice as long as a length of the implant proximal coupling member.
Clause 36. The assembly of Clause 35, wherein the release wire distal portion comprises a length of at least about 2.5 times as long as a length of the implant proximal coupling member.
Clause 37. The assembly of any of Clauses 31-36, wherein in the engaged position, the release wire distal portion extends into a loop of the implant.
Clause 38. An assembly for delivering an implant into a body vessel, the implant having a proximal coupling member, the assembly comprising: a sheath comprising a lumen, an inner surface, a distal end, and a longitudinal axis; and a core member extending longitudinally within the sheath lumen, the core member comprising a pusher member and at least one engagement arm extending distally of the pusher member, the engagement arm comprising a protrusion extending radially inwardly toward the longitudinal axis when the core member is positioned within the sheath lumen, the engagement arm having an engaged position in which the protrusion is spaced at a first distance from the longitudinal axis and a disengaged position in which the protrusion is spaced at a second distance from the longitudinal axis, the second distance being greater than the first distance.
Clause 39. The assembly of Clause 38, wherein the engagement arm is biased to radially diverge from the longitudinal axis.
Clause 40. The assembly of any one of Clauses 38 or 39, wherein the core member comprises a plurality of engagement arms.
Clause 41. The assembly of Clause 40, wherein each of the plurality of engagement arms is biased to radially diverge from each other when unconstrained by the sheath.
Clause 42. The assembly of any one of Clauses 40-41, wherein the pusher member is distally advanceable within the sheath lumen to move the plurality of engagement arms from the engaged position to the disengaged position.
Clause 43. The assembly of any one of Clauses 38-42, wherein the pusher member and the engagement arm are movable relative to each other.
Clause 44. The assembly of any one of Clauses 38-43, wherein the pusher member and the engagement arm are formed from separate components.
Clause 45. The assembly of any one of Clauses 38-44, wherein the protrusion is positioned at a distal end of the engagement arm.
Clause 46. The assembly of any one of Clauses 38-45, wherein the protrusion is positioned proximal to a distal end of the engagement arm.
Clause 47. The assembly of any one of Clauses 38-46, wherein in the engaged position, a distal end of the pusher member is longitudinally spaced apart from the protrusion to provide an engagement region in which the proximal coupling member of the implant is engaged.
Clause 48. An assembly for delivering an implant into a body vessel, the assembly comprising: a first slidable member comprising proximal and distal ends, the first slidable member being operably coupled to a pusher component, the first slidable member comprising an outer surface and a groove along the outer surface; a second slidable member comprising proximal and distal ends and a tubular component having a lumen through which the pusher component is disposed, the second slidable member being operably coupled to a sheath; and a release pin comprising a tab and an engagement portion, the engagement portion being removably couplable to the groove of the first slidable member to maintain a spacing between distal ends of the first slidable member and the second slidable member, the release pin being movable to permit the distal end of the first slidable member to be advanced distally toward the distal end of the second slidable member to facilitate release of the implant from the assembly.
Clause 49. The assembly of Clause 48, wherein the release pin comprises an open socket configured to engage with the groove of the first slidable member.
Clause 50. The assembly of any one of Clauses 48 or 49, wherein the release pin comprises an open socket configured to snap onto the groove of the first slidable member.
Clause 51. The assembly of any one of Clauses 48-50, wherein the groove comprises a circumferential indentation formed along the outer surface of the first slidable member.
Clause 52. The assembly of any one of Clauses 48-51, further comprising a main handle, the main handle comprising a tubular component having a lumen and a notch formed therein, the notch extending radially toward the lumen of the tubular component, the tubular component lumen being configured to receive the first and second slidable members therethrough, the second slidable member comprising a second groove, wherein the assembly further comprises a second release pin configured to extend through the main handle notch to engage the second groove of the second slidable member in a first configuration in which the first and second slidable members are longitudinally fixed relative to the main handle.
Clause 53. The assembly of Clause 52, wherein the second release pin comprises an open socket configured to engage with the second groove of the second slidable member.
Clause 54. The assembly of any one of Clauses 52 or 53, wherein the second release pin comprises an open socket configured to snap onto the second groove of the second slidable member.
Clause 54. An assembly comprising any of the devices, implants, or components recited in any one of Clauses 1-53.
Further ConsiderationsIn some embodiments, any of the clauses herein may depend from any one of the independent clauses or any one of the dependent clauses. In one aspect, any of the clauses (e.g., dependent or independent clauses) may be combined with any other one or more clauses (e.g., dependent or independent clauses). In one aspect, a claim may include some or all of the words (e.g., steps, operations, means or components) recited in a clause, a sentence, a phrase or a paragraph. In one aspect, a claim may include some or all of the words recited in one or more clauses, sentences, phrases or paragraphs. In one aspect, some of the words in each of the clauses, sentences, phrases or paragraphs may be removed. In one aspect, additional words or elements may be added to a clause, a sentence, a phrase or a paragraph. In one aspect, the subject technology may be implemented without utilizing some of the components, elements, functions or operations described herein. In one aspect, the subject technology may be implemented utilizing additional components, elements, functions or operations.
The foregoing description is provided to enable a person skilled in the art to practice the various configurations described herein. While the subject technology has been particularly described with reference to the various figures and configurations, it should be understood that these are for illustration purposes only and should not be taken as limiting the scope of the subject technology.
There may be many other ways to implement the subject technology. Various functions and elements described herein may be partitioned differently from those shown without departing from the scope of the subject technology. Various modifications to these configurations will be readily apparent to those skilled in the art, and generic principles defined herein may be applied to other configurations. Thus, many changes and modifications may be made to the subject technology, by one having ordinary skill in the art, without departing from the scope of the subject technology.
It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method clauses present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.
As used herein, the phrase “at least one of” preceding a series of items, with the term “and” or “or” to separate any of the items, modifies the list as a whole, rather than each member of the list (i.e., each item). The phrase “at least one of” does not require selection of at least one of each item listed; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” each refer to only A, only B, or only C; any combination of A, B, and C; and/or at least one of each of A, B, and C.
Terms such as “top,” “bottom,” “front,” “rear” and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.
Furthermore, to the extent that the term “include,” “have,” or the like is used in the description or the Clauses, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a Clause.
The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments.
A reference to an element in the singular is not intended to mean “one and only one” unless specifically stated, but rather “one or more.” Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. The term “some” refers to one or more. Underlined and/or italicized headings and subheadings are used for convenience only, do not limit the subject technology, and are not referred to in connection with the interpretation of the description of the subject technology. All structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the subject technology. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the above description.
While certain aspects and embodiments of the inventions have been described, these have been presented by way of example only, and are not intended to limit the scope of the inventions. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms without departing from the spirit thereof.
Claims
1. An assembly for delivering an implant into a body vessel, the implant having a proximal coupling member, the assembly comprising:
- a sheath comprising a lumen, an inner surface, and a distal end; and
- an engagement member extending within the sheath lumen, the engagement member comprising a distal end portion having a socket extending from an outer surface of the distal end portion into the engagement member, the socket having an inner profile greater than an outer profile of the implant proximal coupling member to permit the implant proximal coupling member to be removably positionable within the socket,
- wherein in an engaged position, the socket is positioned proximal to the sheath distal end to permit the sheath inner surface and the socket to collectively restrict longitudinal movement of the implant proximal coupling member out of the socket, and wherein in a released position, the socket is positioned distal to the sheath distal end to permit the implant proximal coupling member to exit the socket.
2. The assembly of claim 1, wherein the engagement member comprises a slotted hypotube and a distal band, the hypotube having inner and outer diameters, the band having an inner diameter equal to or greater than the hypotube outer diameter and an outer profile of the engagement member distal end portion to permit the engagement member distal end portion to be slidably receivable within the band.
3. The assembly of claim 1, wherein the socket of the engagement member distal end portion comprises a first void extending into the distal end portion at a first depth and a second void extending into the distal end portion at a second depth, less than the first depth, the second void extending from a distal end of the distal end portion proximally toward the first void.
4. The assembly of claim 1, wherein the engagement member comprises a core member coupled to the distal end portion, the core member having an outer diameter less than an outer diameter of the distal end portion.
5. The assembly of claim 1, further comprising a catheter having a lumen, the sheath extending within the catheter lumen.
6. The assembly of claim 1, further comprising an ejection wire coupled to the engagement member distal end portion and extending proximally across the socket, the ejection wire having (i) a recessed configuration in which the ejection wire is slack and extends along a bottom surface of the socket and (ii) an ejection configuration in which the ejection wire is taut and extends transversely across the socket, wherein the ejection wire permits positioning of the implant proximal coupling member within the socket in the recessed configuration and movement of the ejection wire to the ejection configuration urges the implant proximal coupling member out of the socket.
7. The assembly of claim 6, wherein the ejection wire extends proximally to a handle assembly, the handle assembly comprising an ejection actuator to permit proximal withdrawal of the ejection wire to cause the ejection wire to move to the ejection configuration.
8. An assembly for delivering an implant into a body vessel, the implant having a proximal coupling member, the assembly comprising:
- a sheath comprising a lumen, an inner surface, a distal end, and a longitudinal axis; and
- a core member extending longitudinally within the sheath lumen, the core member comprising a pusher member and at least one engagement arm extending distally of the pusher member, the engagement arm comprising a protrusion extending radially inwardly toward the longitudinal axis when the core member is positioned within the sheath lumen, the engagement arm having an engaged position in which the protrusion is spaced at a first distance from the longitudinal axis and a disengaged position in which the protrusion is spaced at a second distance from the longitudinal axis, the second distance being greater than the first distance.
9. The assembly of claim 8, wherein the engagement arm is biased to radially diverge from the longitudinal axis.
10. The assembly of claim 8, wherein the core member comprises a plurality of engagement arms.
11. The assembly of claim 10, wherein the pusher member is distally advanceable within the sheath lumen to move the plurality of engagement arms from the engaged position to the disengaged position.
12. The assembly of claim 8, wherein the pusher member and the engagement arm are movable relative to each other.
13. The assembly of claim 8, wherein the protrusion is positioned at a distal end of the engagement arm.
14. The assembly of claim 8, wherein in the engaged position, a distal end of the pusher member is longitudinally spaced apart from the protrusion to provide an engagement region in which the proximal coupling member of the implant is engaged.
15. An assembly for delivering an implant into a body vessel, the assembly comprising:
- a first slidable member comprising proximal and distal ends, the first slidable member being operably coupled to a pusher component, the first slidable member comprising an outer surface and a groove along the outer surface;
- a second slidable member comprising proximal and distal ends and a tubular component having a lumen through which the pusher component is disposed, the second slidable member being operably coupled to a sheath; and
- a release pin comprising a tab and an engagement portion, the engagement portion being removably couplable to the groove of the first slidable member to maintain a spacing between distal ends of the first slidable member and the second slidable member, the release pin being movable to permit the distal end of the first slidable member to be advanced distally toward the distal end of the second slidable member to facilitate release of the implant from the assembly.
16. The assembly of claim 15, wherein the release pin comprises an open socket configured to engage with the groove of the first slidable member.
17. The assembly of claim 15, wherein the release pin comprises an open socket configured to snap onto the groove of the first slidable member.
18. The assembly of claim 15, wherein the groove comprises a circumferential indentation formed along the outer surface of the first slidable member.
19. The assembly of claim 15, further comprising a main handle, the main handle comprising a tubular component having a lumen and a notch formed therein, the notch extending radially toward the lumen of the tubular component, the tubular component lumen being configured to receive the first and second slidable members therethrough, the second slidable member comprising a second groove, wherein the assembly further comprises a second release pin configured to extend through the main handle notch to engage the second groove of the second slidable member in a first configuration in which the first and second slidable members are longitudinally fixed relative to the main handle.
20. The assembly of claim 19, wherein the second release pin comprises an open socket configured to engage with the second groove of the second slidable member.
Type: Application
Filed: Mar 31, 2017
Publication Date: Nov 9, 2017
Patent Grant number: 10813644
Inventor: Leon RUDAKOV (San Marcos, CA)
Application Number: 15/476,873
